Ganciclovir EP Impurity C

Development and validation of a high performance liquid chromatographic method for determination of cyclosporine-A from biodegradable intraocular implants
Juliana Barbosa SalibaI, Armando da Silva Cunha JuniorI; Elionai Cassiana de Lima GomesI; Herman Sander MansurII; Gisele Rodrigues da Silva
Quim. Nova, Vol. 34, No. 1, 140-144, 2011

Ganciclovir EP Impurity C is chemically 2-Amino-9-[[(1RS)-2-chloro-1-(hydroxymethyl)ethoxy]methyl]-1,9-dihydro-6H-purin-6-one (as per EP) ; 2-Amino-9-{[(1-chloro-3- hydroxypropan-2-yl)oxy]methyl}-1,9-dihydro-6H-purin-6-one (as per USP). It is also known as Monochloroganciclovir (USP). Ganciclovir EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Ganciclovir EP Impurity C can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Ganciclovir.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.